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Enhertu Racks Up Another EU Approval in Second-Line HER2-Positive Metastatic Breast Cancer

NEW YORK – AstraZeneca and Daiichi Sankyo said Tuesday that Enhertu (trastuzumab deruxtecan) was approved in the European Union for patients with unresectable or metastatic HER2-positive breast cancer who have received at least one other anti-HER2 therapy.

The European Medicines Agency's Committee for Medicinal Products for Human Use previously recommended Enhertu for that indication based on results from the DESTINY-Breast03 Phase III trial. In that trial, the risk of disease progression or death was reduced by 72 percent for patients receiving Enhertu compared to those on Genentech's Kadcyla (trastuzumab emtansine). After 12 months, 75.8 percent of patients on Enhertu had no disease progression at 12 months, compared to 34.1 percent on Kadcyla.

Enhertu was approved by the US Food and Drug Administration in May in this same second-line setting.

In Europe, Enhertu is also approved as a third-line treatment for patients with metastatic, HER2-positive breast cancer after at least two anti-HER2 treatments. The European Commission has extended the market protection period for Enhertu in this setting by one year based on its clinical benefit compared to other approved therapies.

"We believe there is a significant need to transform outcomes for patients with HER2-positive metastatic breast cancer in Europe," Daiichi Sankyo President and CEO Ken Keller said in a statement. "In DESTINY-Breast03, treatment with Enhertu demonstrated superior progression-free survival and a doubling of the response rate compared to another HER2-directed [antibody-drug conjugates]. With this approval we are now able to offer patients with HER2-positive metastatic breast cancer another option earlier in their treatment."